Length of self-retaining suture and method and device for using the same

ABSTRACT

A method and device for anchoring a length of self-retaining suture. The method of anchoring includes providing for an assembly having a length of self-retaining suture and a suture insertion device. The length of suture includes at least a portion of the length having a plurality of retainers thereon extending in a first direction. The insertion device has a length and a recess to receive a portion of the suture length. The method further includes placing a portion of the suture length in the recess and inserting the device into the body of a mammal until the recess reaches a predetermined location thereby forming an insertion pathway. The method further includes retrieving the insertion device from the body by moving the insertion device in a direction substantially opposed to the insertion pathway.

BACKGROUND OF INVENTION

The present invention relates generally to an improved length ofself-retaining suture and, more particularly, relates to convergingsections of self-retaining suture as well as the method and device forusing the same.

Self-retaining sutures have been used in the past in many differentsurgical applications. Self-retaining sutures have been shown to performparticularly well in binding together various body parts such as skin,muscle tissue, organs, blood vessels, tendons, organs and the like.Self-retaining sutures are advantageous to the surgical team becausethey provide an effective ligature of tissue without the requirement ofan anchoring suture knot which can be difficult to tie and which cancause damage to tissue during the wound healing process. Self-retainingsutures also simplify many tissue repair applications by more evenlydistributing repair retention forces along the length of the suture. Theoptimization of self-retaining sutures is disclosed in detail in U.S.Patent Publication US 2004/0060409A and is incorporated herein in itsentirety.

Typically, self-retaining sutures have been used to bind mammalian bodyparts together by passing a first length of self-retaining suturethrough a first section of tissue to be bound in a direction in whichthe retainers may pass relatively freely in one direction through thetissue, but will resist movement if the suture is moved in the directionopposed to the insertion direction. Then a second length of suture ispassed through a second section of tissue in a second direction.Finally, the surgeon joins the two lengths together by tying them orotherwise binding them together.

One alternative method for use of a self-retaining suture is to use asingle length of rigid self-retaining suture having a first end, asecond end and the retainers disposed on the length of the suture in abidirectional fashion. A portion of the length of the suture hasretainers facing a first end and a portion of the length of the suturehas retainers facing the second end. The suture binds tissue together byinserting the first end in a first section of tissue and inserting thesecond end in a second section of tissue. The diverging retainersresisted movement of the sections away from the wound and help bind themtogether. This retainer design and methodology is disclosed more fullyin U.S. Pat. No. 6,241,747B1 and is incorporated herein in its entirety.

Further, there are devices for use in inserting self-retaining suturesinto the body of a mammal. These include tubular instruments having ahollow portion for holding a length of self-retaining suture. The end ofthe instrument includes a holding point for a pointed first end of thesuture length and the front of the instrument includes a handle. In use,the end of the instrument is inserted into the body of a mammal at thepoint. The instrument, guided by the user holding it at the handle, isinserted along a pathway through an incision or wound for closure and upthrough the tissue, or the like, where the pointed end can clear thesubject tissue. The user, while holding the pointed end, reversesdirection along the insertion pathway with the instrument. This releasesthe length of suture within the instrument and enables the retainers tograsp the surrounding tissue. The instrument clears the wound area andthe retainers holding the surrounding tissue keep the wound closed. Sucha device is disclosed in U.S. Pat. No. 5,342,376.

Other self-retaining suture technologies are known to the applicants.Table 1 summarizes applicable self-retaining suture technology. Table 1is attached and, along with its foreign counterparts and anycontinuations and/or divisionals, is incorporated herein by reference inits entirety.

In spite of the advances made to date relating to self-retaining suturetechnology, there does not exist a suture length made up of one or moresections containing converging retainer patterns that facilitates theplacement of a suture without an attached needle. Such placement wouldbe advantageous in several surgical tissue repair applications whereinthe location of the tissue to be repaired constrains the passage andretrieval of an attached suture insertion device or where adjacenttissues could be harmed by the passage of the attached needle such asthe passage of a needle past the bladder during the placement of abladder neck suspension sling. Further, such placement would be usefulin certain cases where robotic or other mechanically assisted surgicalmethods are employed in which simplified suture anchoring methods aredesired. Also, such placement would be advantageous in fixingtherapeutic devices to delicate tissues such as tumors in which suchdevices would operate more effectively if they were placed with minimaltissue disruption and if such therapeutic devices were immobilizedduring the period of therapeutic treatment. Also, such placement reducesthe number of attached needles that must be retrieved from the surgicaltissue. Thus reducing the established risk of inadvertently leavingneedles in the patient after surgery is completed. Further, themanipulation of needles during this process of thread passage and needleretrieval is a well known risk for “needle stick” to the operator thatcan lead to the transmission of blood borne pathogens such as HIV andhepatitis.

At present, there does not exist any system or method where a length ofsuture is inserted with a detachable suture insertion device where thesuture insertion device may be easily retracted along the needle'sinsertion pathway. Presently, after tissue or the like is anchored, thesurgeon in some cases must continue to move the suture insertion devicefurther through tissue to retrieve the needle. This may result infurther damage to the tissue, as discussed above. When the surgeon movesthe suture insertion device further through tissue to enable the sutureinsertion device to exit the body, this also results in the formation ofa suture insertion-device-exiting-pathway which creates an opportunityfor the suture to migrate from its initial placement position Suchmigration can lead to movement of the anchored tissue or disconnectionof joined tissues relative to each other. Such movement could lead tocomplete or partial failure of the procedure. Also, the suture itselfmay migrate into positions that are harmful to adjacent tissue andorgans.

A further disadvantage of the present state of the art is that the areatissue surrounding the suture placement may become damaged during theprocedure because of the surgeon's need to retrieve the attached needle.Presently, a surgeon must not only insert a suture and any attachment tothe desired location, but to retrieve the needle, the surgeon must movethe needle through a particular area of tissue to enable the needle toexit. Alternatively, the surgeon may choose to try to reverse theattached needle's pathway at the point of suture placement. In eithercase, there can be significant disruption to the tissue in thesurrounding area. This can become a critical issue where the surgeon isworking in the area of a cancerous tumor. If the tumor becomes damagedor as a result of the disruption to tissue, the procedure isineffective, the cancer may spread or the procedure to treat the cancermay fail. Thus, there is no system or method of placing a suture at adesired location that leaves the surrounding tissue unharmed andundamaged.

Another disadvantage of the present state of art relates to surgicalprocedures that require a significantly deep incision relative to thesize of the incision at the skin level. In particular, endoscopicprocedures and surgeries often require minimum incisions at the skinlevel and yet may be quite deep. As a result, it is often difficult forthe surgeon to work in such a cramped environment. Closing this accessport is challenging to do with conventional attached needles, especiallyat the deepest portion s of the narrow opening where there is littleroom to manipulate a needle driver and forceps to grasp and retrieve anattached needle.

One version of a converging self-retaining suture pattern is in a suturelength made up of a continuous loop having converging retainers along atleast a portion of the length, wherein the loop is inserted into asection of tissue to support a body part of a mammal. Further, there isno method or device at present that enables a user to accurately andeffectively insert a looped length of self-retaining suture into thebody of a mammal where the insertion end of the suture length remainswithin the body of a mammal without the need for holding, joining orpulling on the insertion end of the suture. Such a method or a devicewould enable a surgeon or other medical personnel to engage inprocedures that would deliver more effective treatment to patients whileminimizing damage to the surrounding tissue. This would provide greatersuccess rates of certain procedures, decrease recovery time, minimizecomplications and thus decrease the overall cost to perform suchprocedures.

Accordingly, it is desired to provide a continuous loop of suture havingconverging retainers on at least a portion of its length where the loopis inserted into the body of a mammal to support a body part.

It is further desired to provide a method and device for inserting alength of suture having converging retainers along at least a portionthereon, where the inserted end remains within the body of the mammaland does not need to be pulled or manually held or joined to anotherlength thereof.

It is yet further desired to provide a method of support a body part ofa mammal by inserting a length of suture having retainers along at leasta portion thereof, where the length of suture remains within theinsertion pathway and the insertion end of the suture does not need tobe held or joined to another length of suture or pulled clear ofinsertion area for the method to be effective.

It is still further desired to provide a method and device forsupporting a body part of a mammal where the length of suture isinserted into the body of mammal at a point that ensures significanteffectiveness in the continued support of the body part.

It is yet further desired to provide a method and device for supportinga body part of a mammal where the procedure is minimally invasive,minimizes damage to the body during the procedure recovery time andreduces the overall cost of performing the procedure.

It is yet further desired to provide a method and device for placingsutures in tissue where the procedure is minimally invasive, minimizesdamage to the body during the repair procedure, minimizes recovery timeand reduces the overall costs of performing the procedure.

It is still further desired to provide a method and device for placingsutures in tissue where the suture is easily detached from the sutureinsertion device and the suture insertion device is able to be retractedfrom the tissue by reversing its travel along the insertion pathway.

It is yet further desired to provide a method and device for anchoring alength of suture in a particular location in tissue in such a mannerthat minimizes the possibility for suture migration and for damage tosurrounding tissue.

It is further desired to provide a method and device for anchoring asuture and attachment such as a marker, tack, tag, chemotherapeutic drugdelivery agent, seroma evacuation tube or the like into the tissue withgreat accuracy and with minimal disruption to surrounding tissue.

It is also desired to provide a method and system for ensuring that allneedles used in a surgical procedure are retrieved.

BRIEF SUMMARY OF INVENTION

The present invention provides for a suture having an elongated bodyhaving a first end, a second end, and a plurality of retainersprojecting from the body. The retainers are disposed on the periphery ofthe body along at least a portion of the length of the body. All of theretainers face the first end. The retainers are configured such thatwhen the length of suture is inserted into the tissue of a mammal theretainers generally flex toward the body during insertion where damageto the tissue by the retainers is minimized, and the retainers generallyresist movement when the suture is pulled in a direction opposed to theinsertion pathway. The suture also has a temporary holding point for aninsertion device to hold the body. The point is located proximate to thefirst end.

The present invention also provides for a continuous length of suturewhere the ends are joined together to form a loop. The loop has a firstlength of suture having an elongate first body. A plurality of firstretainers project from the first body in a first direction. The firstretainers are disposed on the periphery of the first body along at leasta portion of the first length. The loop also has a second length havinga plurality of second retainers projecting from the second body in asecond direction, the second direction being opposite to the firstdirection. The second retainers are disposed on the periphery of thesecond body along at least a portion of the second length. The loop hasan intervening length located between the first and second lengths,whereby all of the first retainers and all of the second retainers facethe intervening length.

The present invention further provides for a continuous length of suturewhere the ends are joined together to form a loop. The loop has a firsthalf having an elongate first half body having a first section, a secondsection and a first intervening section. A plurality of first retainersproject peripherally from the first section along at least a portionthereof, in a first direction. A plurality of second retainers projectperipherally from the second section along at least a portion thereof ina direction opposed to the first direction. The intervening section isdisposed between the first and second sections. The first and secondretainers face the first intervening section. The loop also has a secondhalf having an elongate second half body having a third section, afourth section and a second intervening section. A plurality of thirdretainers project peripherally from the third section along at least aportion thereof, in a second direction. A plurality of fourth retainersproject peripherally from the fourth section along at least a portionthereof in a direction opposed to the second direction. The secondintervening section is disposed between the third and fourth sectionsand the third and fourth retainers face the second intervening section.

The present invention still further provides for a continuous length ofsuture where the ends are joined together to form a loop. The loop has aplurality of sections of suture length. Each section has an elongatebody having a first part, a second part and an intervening part locatedbetween the first part and the second part. A plurality of firstretainers project from the first part in a first direction. The firstretainers are disposed on the periphery of the body along at least aportion of the first part. A plurality of second retainers project fromthe second part in a second direction. The second direction beingopposite to the first direction. The second retainers are disposed onthe periphery of the body along at least a portion of the second part.Substantially all of the first retainers of the first part of eachsection and substantially all of the second retainers from the secondpart of each section face the intervening part of each section.

The present invention further provides for a method of supporting anobject within the body of a mammal. The steps include providing acontinuous length of suture where the ends of the suture are joinedforming a loop, the loop having a first half and a second half. Thefirst half of the loop has an elongate first half body having a firstsection, a second section and a first intervening section, a pluralityof first retainers projecting peripherally from the first section alongat least a portion thereof, in a first direction, a plurality of secondretainers projecting peripherally from the second section along at leasta portion thereof in a direction opposed to the first direction, and theintervening section disposed between the first and second sections wherethe first and second retainers face the intervening section. The loopalso has a second half having an elongate second half body having athird section, a fourth section and a second intervening section, aplurality of third retainers projecting peripherally from the thirdsection along at least a portion thereof, in a second direction, aplurality of fourth retainers projecting peripherally from the fourthsection along at least a portion thereof in a direction opposed to thesecond direction, and the second intervening section disposed betweenthe third and fourth sections where the third and fourth retainers facethe second intervening section. The method further includes placing thepoint in the loop where the first and second halves are joined under anobject within the body of a mammal to be supported. The method includesinserting the first half of the loop into a first section of tissue of amammal at a point along the first intervening section forming a firstinsertion pathway, and inserting the second half of the loop into asecond section of tissue forming a second insertion pathway, whereby theobject within the body of a mammal is supported.

The present invention further provides for a method of supporting anobject within the body of a mammal. The method includes the step ofproviding a continuous length of suture where the ends of the suture arejoined forming a loop. The loop has a first length of suture having anelongate first body, a plurality of first retainers projecting from thefirst body in a first direction, the first retainers being disposed onthe periphery of the first body along at least a portion of the firstlength. The loop also has a second length having a plurality of secondretainers projecting from the second body in a second direction, thesecond direction being opposite to the first direction, the secondretainers being disposed on the periphery of the second body along atleast a portion of the second length. The loop has an intervening lengthlocated between the first and second lengths, whereby substantially allof the first retainers and substantially all of the second retainersface the intervening length. The loop also has a diverging length wherethe first length and second lengths are joined and where the firstretainers and second retainers diverge and face in opposing direction.The method also includes the steps of placing at least a portion of thediverging length under an object within the body of a mammal to besupported, and inserting the suture into a section of tissue of a mammalat a point along the intervening section forming an insertion pathway,whereby the object within the body of a mammal is supported.

The present invention also provides for a method of supporting an objectwithin the body of a mammal by providing a continuous length of suturewhere the ends of the suture are joined forming a loop. The loop has aplurality of sections of suture length. Each section has an elongatebody having a first part, a second part and an intervening part locatedbetween the first part and the second part. A plurality of firstretainers project from the first part in a first direction, the firstretainers being disposed on the periphery of the body along at least aportion of the first part. A plurality of second retainers project fromthe second part in a second direction, the second direction beingopposite to the first direction, the second retainers being disposed onthe periphery of the second body along at least a portion of the secondlength. The first retainers of the first part of each section and thesecond retainers from the second part of each section face theintervening part of each section. The method further includes the stepsof placing a portion of the length of suture between sections under anobject within the body of a mammal to be supported, inserting a firstsection of suture length into a first section of tissue of a mammal at apoint along the first intervening part forming a first insertionpathway, and inserting the each remaining section of suture length intoa subsequent section of tissue forming subsequent insertion pathways,whereby the object within the body of a mammal is supported.

The present invention yet further provides for a suture insertion devicefor use in inserting a length of suture into the tissue of a mammal. Thesuture insertion device has a substantially rigid, elongate body havinga first end, a second end and a length. The suture insertion device alsohas a recess proximate to the first end to receive a cross-section ofsuture, and a forwardly extending finger located at the rearward end ofthe recess for maintaining the suture within the recess duringinsertion.

The present invention still further provides for an assembly forinserting a length of suture within the body of a mammal. The assemblyhas a length of suture having an elongated body having a first end, asecond end, and a plurality of retainers projecting from the body. Theretainers are disposed on the periphery of the body along at least aportion of the length of the body. The retainers face the first end, andare configured such that when the length of suture is inserted into thetissue of a mammal the retainers generally flex toward the body duringinsertion where damage to the tissue by the retainers is minimized, andthe retainers are generally rigid and resist movement when the suture ispulled in a direction opposed to the insertion pathway. The length ofsuture also has a temporary holding point for receipt within a recesswithin a suture insertion device to hold the body. The temporary holdingpoint is located proximate to the first end. The assembly also has asuture insertion device having a substantially rigid, elongate bodyhaving a first end, a second end and a length, a recess proximate to thefirst end to receive a cross-section of suture, and a forwardlyextending finger located at the rearward end of the recess. When thetemporary holding point is received within the recess of the sutureinsertion device, the length of suture is inserted within the body of amammal via the suture insertion device in a first direction with thelength of suture received within the recess, and the is withdrawn bymoving the suture insertion device in a direction opposed to the firstdirection, the holding point being released from its position within therecess and thus frees the suture insertion device for removal therefrom.

The present invention further provides for another assembly forinserting a length of suture within the body of a mammal. The assemblyincludes a suture having an elongated body having a first end, a secondend, and an intervening point located between the first and second ends.The suture also includes a plurality of retainers projecting from thebody, the retainers being disposed on the periphery of the body along atleast a portion of the length of the body, all of the retainers fromboth ends facing the intervening point. The retainers are configuredsuch that when the length of suture is inserted into the tissue of amammal at the intervening point, the retainers generally flex toward thebody during insertion where damage to the tissue by the retainers isminimized, and the retainers are generally rigid and resist movementwhen the suture is pulled in a direction opposed to the insertionpathway. The assembly also includes a suture insertion device having asubstantially rigid, elongate body having a first end, a second end anda length, a recess proximate to the first end to receive a cross-sectionof suture, and a forwardly extending finger located at the rearward endof the recess. When the intervening point is received within the recessof the suture insertion device, the length of suture is inserted withinthe body of a mammal by moving the suture insertion device in a firstdirection within the body of a mammal, when at least a portion of thelength of suture is received within the body of the mammal, the sutureinsertion device is withdrawn from the body of a mammal by moving thesuture insertion device in a direction opposed to the first direction,as a result of the opposed movement of the suture insertion device, theintervening point is released from its position within the recess andenables the suture insertion device to be withdrawn while allowing thelength of suture to remain within the body of a mammal.

The present invention provides for a further assembly for inserting alength of suture within the body of a mammal. The assembly has acontinuous length of suture and a suture insertion device. Thecontinuous length of suture is joined at the ends to form a loop. Theloop has a first length of suture having an elongate first body, aplurality of first retainers projecting from the first body in a firstdirection, the first retainers being disposed on the periphery of thefirst body along at least a portion of the first length. The loop has asecond length having a plurality of second retainers projecting from thesecond body in a second direction, the second direction being oppositeto the first direction, the second retainers being disposed on theperiphery of the second body along at least a portion of the secondlength. The loop has an intervening length located between the first andsecond lengths, and substantially all of the first retainers andsubstantially all of the second retainers face the intervening length.The suture insertion device has a substantially rigid, elongate bodyhaving a first end, a second end and a length, a recess proximate to thefirst end to receive a cross-section of suture, and a forwardlyextending finger located at the rearward end of the recess. When theintervening length is received within the recess of the suture insertiondevice, the length of suture is inserted within the body of a mammal bymoving the suture insertion device in an insertion direction. When atleast a portion of the length of suture is received within the body ofthe mammal, the suture insertion device is withdrawn from the body of amammal by moving the suture insertion device in a direction opposed tothe insertion direction, as a result of the opposed movement of thesuture insertion device, the intervening length is released from itsposition within the recess and the suture insertion device is able to bewithdrawn while enabling the length of suture to remain within the bodyof a mammal.

The present invention still further provides an assembly for inserting alength of suture within the body of a mammal. The assembly includes acontinuous length of suture where the ends are joined together to form aloop, and a suture insertion device. The loop has a first half having anelongate first half body having a first section, a second section and afirst intervening section. A plurality of first retainers projectperipherally from the first section along at least a portion thereof, ina first direction. A plurality of second retainers project peripherallyfrom the second section along at least a portion thereof in a directionopposed to the first direction. The intervening section is disposedbetween the first and second sections where the first and secondretainers face the first intervening section. The second half of theloop has an elongate second half body having a third section, a forthsection and a second intervening section. A plurality of third retainersproject peripherally from the third section along at least a portionthereof, in a second direction. A plurality of fourth retainers projectperipherally from the fourth section along at least a portion thereof ina direction opposed to the second direction. The second interveningsection is disposed between the third and fourth sections where thethird and fourth retainers face the second intervening section. Thesuture insertion device has a substantially rigid, elongate body havinga first end, a second end and a length, a recess proximate to the firstend to receive a cross-section of suture, and a forwardly extendingfinger located at the rearward end of the recess. When the firstintervening length is received within the recess of the suture insertiondevice, the first half is inserted within the body of a mammal by movingthe suture insertion device in a first insertion direction. When atleast a portion of the first half is received within the body of themammal, the suture insertion device is withdrawn from the body of amammal by moving the suture insertion device in a direction opposed tothe first insertion direction. As a result of the opposed movement ofthe suture insertion device, the first intervening length is releasedfrom its position within the recess, and enables the suture insertiondevice to be withdrawn while enabling the first half to remain withinthe body of a mammal. When the second intervening length is receivedwithin the recess of the suture insertion device, the second half isinserted within the body of a mammal by moving the suture insertiondevice in a second insertion direction. When at least a portion of thesecond half is received within the body of the mammal, the sutureinsertion device is withdrawn from the body of a mammal by moving thesuture insertion device in a direction opposed to the second insertiondirection. As a result of the opposed movement of the suture insertiondevice, the second intervening length is released from its positionwithin the recess and enables the suture insertion device to bewithdrawn while enabling the second half to remain within the body ofthe mammal.

The present invention provides for another assembly for inserting alength of suture within the body of a mammal. The assembly includes acontinuous length of suture where the ends are joined together to form aloop and a suture insertion device. The loop has a plurality of sectionsof suture length. Each section has an elongate body having a first part,a second part and an intervening part located between the first part andthe second part. A plurality of first retainers project from the firstpart in a first direction. The first retainers are disposed on theperiphery of the body along at least a portion of the first part. Aplurality of second retainers project from the second part in a seconddirection, the second direction being opposite to the first direction.The second retainers are disposed on the periphery of the second bodyalong at least a portion of the second length. Substantially of thefirst retainers of the first part of each section and substantially allof the second retainers from the second part of each section face theintervening part of each section. The suture insertion device has asubstantially rigid, elongate body having a first end, a second end anda length, a recess proximate to the first end to receive a cross-sectionof suture, and a forwardly extending finger located at the rearward endof the recess. When each intervening part is separately received withinthe recess of the suture insertion device, the corresponding section ofsuture is inserted within the body of a mammal by moving the sutureinsertion device in a first insertion direction. When at least a portionof that section of suture is received within the body of the mammal, thesuture insertion device is withdrawn from the body of a mammal by movingthe suture insertion device in a direction opposed to the firstinsertion direction, as a result of the opposed movement of the sutureinsertion device, the intervening part is released from its positionwithin the recess and enables the suture insertion device to bewithdrawn while enabling the section of suture inserted to remain withinthe body of the mammal. The insertion of remaining sections is similarlyrepeated until all sections of the length of suture are inserted into abody of a mammal.

The present invention further provides for a method of anchoring asuture within the body of a mammal. The method includes the steps ofproviding an assembly having a length of suture and a suture insertiondevice. The length of suture has an elongated body having a first end, asecond end, and a plurality of retainers projecting from the body. Theretainers are disposed on the periphery of the body along at least aportion of the length of the body. The retainers face the first end, andare configured such that when the length of suture is inserted into thebody of a mammal the retainers generally flex toward the body duringinsertion where damage to the tissue by the retainers is minimized, andthe retainers are generally rigid and resist movement when the suture ispulled in a direction opposed to the insertion pathway. The length ofsuture also has a temporary holding point to be received by a sutureinsertion device. The temporary holding point is located proximate tothe first end. The suture insertion device has a substantially rigid,elongate body having a first end, a second end and a length, and arecess proximate to the first end to receive a length of suture. Themethod further includes placing a portion of the temporary holding pointwithin the recess of the suture insertion device, inserting the sutureinsertion device, so as to form an insertion pathway, into the body of amammal until the first end of the suture reaches a predeterminedlocation, retrieving the suture insertion device in a directionsubstantially opposed to the insertion pathway until the sutureinsertion device is removed from the body of a mammal, and causing thelength of suture to remain in the body of a mammal.

The present invention still further provides for a method of anchoring asuture within the body of a mammal. The method includes providing anassembly having a length of suture where the ends are joined together toform a loop. The loop has a first length of suture having an elongatefirst body, a plurality of first retainers projecting from the firstbody in a first direction, the first retainers being disposed on theperiphery of the first body along at least a portion of the firstlength, a second length having a plurality of second retainersprojecting from the second body in a second direction, the seconddirection being opposite to the first direction, the second retainersbeing disposed on the periphery of the second body along at least aportion of the second length, and an intervening length located betweenthe first and second lengths, whereby all of the first retainers and allof the second retainers face the intervening length. The assemblyfurther includes a suture insertion device having a substantially rigid,elongate body having a first end, a second end and a length, and arecess proximate to the first end to receive a length of suture. Themethod further includes placing a portion of the intervening lengthwithin the recess of the suture insertion device, inserting the sutureinsertion device into the body of a mammal so as to form a sutureinsertion device insertion pathway until the recess reaches apredetermined location, retrieving the suture insertion devicesubstantially along the insertion pathway until the suture insertiondevice is removed from the body of a mammal, and causing the length ofsuture to remain in the body of a mammal.

The present invention further provides for a method of anchoring asuture within the body of a mammal. The method includes providing anassembly having a continuous length of suture where the ends are joinedtogether to form a loop. The loop has a first half having an elongatefirst half body having a first section, a second section and a firstintervening section, a plurality of first retainers projectingperipherally from the first section along at least a portion thereof, ina first direction, a plurality of second retainers projectingperipherally from the second section along at least a portion thereof ina direction opposed to the first direction, and the intervening sectiondisposed between the first and second sections where the first andsecond retainers face the first intervening section; and a second halfhaving an elongate second half body having a third section, a fourthsection and a second intervening section, a plurality of third retainersprojecting peripherally from the third section along at least a portionthereof, in a second direction, a plurality of fourth retainersprojecting peripherally from the fourth section along at least a portionthereof in a direction opposed to the second direction, and the secondintervening section disposed between the third and fourth sections wherethe third and fourth retainers face the second intervening section. Theassembly also includes a suture insertion device having a substantiallyrigid, elongate body having a first end, a second end and a length, anda recess proximate to the first end to receive a length of suture. Themethod also includes placing a portion of the first intervening lengthof suture within the recess of the suture insertion device, insertingthe suture insertion device into the body of a mammal until the recessreaches a predetermined location so as to form a first suture insertiondevice insertion pathway, retrieving the suture insertion devicesubstantially along the insertion pathway until the suture insertiondevice is removed from the body of a mammal. The method further includesplacing a portion of the second intervening length of suture within therecess of the suture insertion device, inserting the suture insertiondevice into the body of a mammal until the recess reaches apredetermined location so as to form a second suture insertion deviceinsertion pathway, retrieving the suture insertion device substantiallyalong the second insertion pathway until the suture insertion device isremoved from the body of a mammal, and causing the length of suture toremain in the body of a mammal.

The present invention still further provides for a method of anchoring asuture within the body of a mammal. The method includes the steps ofproviding an assembly having a continuous length of suture where theends are joined together to form a loop, and a suture insertion device.The loop has a plurality of sections of suture length, each sectionhaving an elongate body having a first part, a second part and anintervening part located between the first part and the second part, aplurality of first retainers projecting from the first part in a firstdirection, the first retainers being disposed on the periphery of thebody along at least a portion of the first part, and a plurality ofsecond retainers projecting from the second part in a second direction,the second direction being opposite to the first direction, the secondretainers being disposed on the periphery of the second body along atleast a portion of the second length, all of the first retainers of thefirst part of each section and all of the second retainers from thesecond part of each section face the intervening part of each section.The suture insertion device has a substantially rigid, elongate bodyhaving a first end, a second end and a length, and a recess proximate tothe first end to receive a length of suture. The method further includesplacing a portion of the intervening part within the recess of thesuture insertion device, inserting the suture insertion device into thebody of a mammal so as to form a suture insertion device insertionpathway until the recess reaches a predetermined location, retrievingthe suture insertion device substantially along the insertion pathwayuntil the suture insertion device is removed from the body of a mammalcausing the length of suture to remain in the body of a mammal, andrepeating the inserting and retrieving steps until all sections of theloop are inserted into the body of a mammal.

The present invention also provides for a self-retaining suture havingan elongated body having a first end, a second end and a first sectionand a second section, a plurality of retainers projecting from the bodyalong the first section in a first direction, and a plurality ofretainers projecting from the body along the second section in a seconddirection. The first direction is opposed to the second direction. Theretainers of the first section face the retainers of the second section,and the retainers being configured such that when the length of sutureis inserted into the tissue of a mammal at the point where the retainersconverge, the retainers generally flex toward the body during insertionwhere damage to the tissue by the retainers is minimized, and theretainers generally resist movement when the suture is pulled in adirection opposed to the insertion pathway.

The present invention yet further provides for a method of using aself-retaining suture comprising the steps of providing a self-retainingsuture having an elongated body having a first end, a second end and afirst section and a second section, a plurality of retainers projectingfrom the body along the first section in a first direction, and aplurality of retainers projecting from the body along the second sectionin a second direction, the first direction being opposed to the seconddirection. The method also includes providing a suture insertion devicehaving a substantially rigid, elongate body having a first device end, asecond device end and a device length, and a recess proximate to thefirst device end to receive a cross section of suture. The methodfurther includes placing a cross-section of the self-retaining sutureinto the recess of the suture insertion device at a place along thelength of the suture between the first and second sections, andinserting the first device end into the body of a mammal so as to forman insertion pathway until the recess reaches a predetermined location.The method further includes retrieving the suture insertion device bysubstantially reversing direction along the insertion pathway until thesuture insertion device is removed from the body of a mammal, andcausing the suture to remain in the body of a mammal, whereby when thesuture is inserted into the tissue of a mammal, the retainers generallyflex toward the body during insertion where damage to the tissue by theretainers is minimized, and the retainers generally resist movement whenthe suture is pulled in a direction opposed to the insertion pathway.

The details of one or more aspects or embodiments are set forth in thedescription below. Other features, objects and advantages will beapparent from the description, the drawings, and the claims. Inaddition, the disclosures of all patents and patent applicationsreferenced herein are incorporated by reference in their entirety.

DESCRIPTION OF DRAWINGS

FIG. 1 is a front view of a first embodiment of the present invention.

FIG. 1A is a front view of a first alternative embodiment of theembodiment of FIG. 1.

FIG. 2A is a front view of a suture insertion device of the presentinvention.

FIG. 2B is a side view of the embodiment of FIG. 2A.

FIG. 3 is a top view of the suture insertion device of FIG. 2A with thefirst embodiment of FIG. 1 held therein.

FIG. 4 is an enlarged sectional view of a portion of the assembly ofFIG. 3 taken along line A-A.

FIG. 5 is a diagrammatic representation of the tested suture lengthhaving converging retainers thereon.

FIG. 6 is a front view of a second alternative embodiment of the presentinvention.

FIG. 7 is a front view of a third alternative embodiment of the presentinvention.

FIG. 7A is a perspective view of the embodiment of FIG. 7 having anobject attached thereto.

FIG. 7B is a front view of the embodiment of FIG. 7 having a tackattached thereto.

FIG. 7C is a front view of a seroma evacuation tube for anchoring to theskin surface.

FIG. 8 is a front view of the fourth alternative embodiment of thepresent invention.

FIG. 9 is a front view of the embodiment of FIG. 9 with a mesh slingattached thereto.

FIG. 10 is a perspective view of the assembly of the embodiment of FIG.8 and the suture insertion device of FIGS. 2A and 2B.

FIG. 11 is a diagrammatic view of the embodiment of FIG. 9 in a proposedinstalled position for use as a support for a human organ.

FIG. 12 is a front view of an alternative embodiment of FIG. 10 in usefor closing an incision where one end of the embodiment of FIG. 10 isinserted using a detachable suture insertion device as shown and theother has an attached curved suture insertion device.

FIG. 12A is a front view of an alternative suture insertion device FIG.12B is a front view of the embodiment of FIG. 12 showing the insertionand removal of the curved suture insertion device, as shown in FIG. 12A.

FIG. 13 is a front view of the fifth alternative embodiment of thepresent invention.

FIG. 14A is a diagrammatic view of the embodiment of FIG. 13 as it isbeing installed.

FIG. 14B is a diagrammatic view of the embodiment of FIG. 13 in itsfully installed position.

FIG. 15 is a front view of an alternative placement of theself-retaining suture of the present invention.

FIG. 16 is a front view of a sixth alternative embodiment of the presentinvention with the suture insertion device of FIGS. 2A and 2B.

FIG. 17 is a table that provides a comparative analysis regarding thepullout strength in ounces of various sutures tested.

DESCRIPTION OF INVENTION

Certain terminology is used herein for convenience only and is not to betaken as a limitation on the invention. For example, words such as“first” and “second”, “forward” and “rearward”, “inner” and “outer”merely describe the configuration shown in the figures. Indeed, thereferenced components may be oriented in any direction and theterminology, therefore, should be understood as encompassing suchvariations unless specified otherwise.

In addition, prior to setting forth the invention, it may be helpful toan understanding thereof to first set forth definitions of certain termsthat are used hereinafter.

“Self-retaining system” refers to a self-retaining suture together withmeans for deploying the suture into tissue. Such deployment meansinclude, without limitation, suture needles and deployment devices aswell as sufficiently rigid and sharp portions on the suture itself topenetrate tissue.

“Self-retaining suture” refers to a suture that does not require a knotor a suture anchor in order to maintain its position into which it isdeployed during a surgical procedure. These may be monofilament suturesor braided sutures, and are positioned in tissue in two stages, namelydeployment and affixation, and include at least one tissue retainer.

“Tissue retainer” (or simply “retainer”) or “barb” refers to a sutureelement having a retainer body projecting from the suture body and aretainer end adapted to penetrate tissue. Each retainer is adapted toresist movement of the suture in a direction other than the direction inwhich the suture is deployed into the tissue by the surgeon, by beingoriented to substantially face the deployment direction. As thetissue-penetrating end of each retainer faces away from the deploymentdirection when moving through tissue during deployment, the tissueretainers should not catch or grab tissue during this phase. Once theself-retaining suture has been deployed, a force exerted in anotherdirection (often substantially opposite to the deployment direction)causes the retainers to be displaced from their deployment positions(i.e., resting substantially along the suture body), forces the retainerends to open from the suture body in a manner that catches andpenetrates into the surrounding tissue, and results in tissue beingcaught between the retainer and the suture body; thereby “anchoring” oraffixing the self retaining suture in place.

“Retainer configurations” refers to configurations of tissue retainersand can include features such as size, shape, surface characteristics,and so forth. These are sometimes also referred to as “barbconfigurations”.

“Suture thread” refers to the filamentary body component of the suture,and, for sutures requiring needle deployment, does not include thesuture needle. The suture thread may be monofilamentary, or,multifilamentary.

“Monofilament suture” or “monofilament” refers to a suture comprising amonofilamentary suture thread.

“Braided suture” refers to a suture comprising a multifilamentary suturethread. The filaments in such suture threads are typically braided,twisted, or woven together.

“Degradable (also referred to as “biodegradable” or “bioabsorbable”)suture” refers to a suture which, after introduction into a tissue isbroken down and absorbed by the body. Typically, the degradation processis at least partially mediated by, or performed in, a biological system.“Degradation” refers to a chain scission process by which a polymerchain is cleaved into oligomers and monomers. Chain scission may occurthrough various mechanisms, including, for example, by chemical reaction(e.g., hydrolysis, oxidation/reduction, enzymatic mechanisms or acombination or these) or by a thermal or photolytic process. Polymerdegradation may be characterized, for example, using gel permeationchromatography (GPC), which monitors the polymer molecular mass changesduring erosion and breakdown. Degradable suture material may includepolymers such as polyglycolic acid, copolymers of glycolide and lactide,copolymers of trimethylene carbonate and glycolide with diethyleneglycol (e.g., MAXON™, Tyco Healthcare Group), terpolymer composed ofglycolide, trimethylene carbonate, and dioxanone (e.g., BIOSYN™[glycolide (60%), trimethylene carbonate (26%), and dioxanone (14%)],Tyco Healthcare Group), copolymers of glycolide, caprolactone,trimethylene carbonate, and lactide (e.g., CAPROSYN™, Tyco HealthcareGroup). These sutures can be in either a braided multifilament form or amonofilament form. The polymers used in the present invention can belinear polymers, branched polymers or multi-axial polymers. Examples ofmulti-axial polymers used in sutures are described in U.S. PatentApplication Publication Nos. 20020161168, 20040024169, and 20040116620.Sutures made from degradable suture material lose tensile strength asthe material degrades.

“Non-degradable (also referred to as “non-absorbable”) suture” refers toa suture comprising material that is not degraded by chain scission suchas chemical reaction processes (e.g., hydrolysis, oxidation/reduction,enzymatic mechanisms or a combination or these) or by a thermal orphotolytic process. Non-degradable suture material includes polyamide(also known as nylon, such as nylon 6 and nylon 6.6), polyester (e.g.,polyethylene terephthlate), polytetrafluoroethylene (e.g., expandedpolytetrafluoroethylene), polyether-ester such as polybutester (blockcopolymer of butylene terephthalate and polytetra methylene etherglycol), polyurethane, metal alloys, metal (e.g., stainless steel wire),polypropylene, polyethelene, silk, and cotton. Sutures made ofnon-degradable suture material are suitable for applications in whichthe suture is meant to remain permanently or is meant to be physicallyremoved from the body.

“Suture diameter” refers to the diameter of the body of the suture. Itis to be understood that a variety of suture lengths may be used withthe sutures described herein and that while the term “diameter” is oftenassociated with a circular periphery, it is to be understood herein toindicate a cross-sectional dimension associated with a periphery of anyshape. Suture sizing is based upon diameter. United States Pharmacopeia(“USP”) designation of suture size runs from 0 to 7 in the larger rangeand 1-0 to 11-0 in the smaller range; in the smaller range, the higherthe value preceding the hyphenated zero, the smaller the suturediameter. The actual diameter of a suture will depend on the suturematerial, so that, by way of example, a suture of size 5-0 and made ofcollagen will have a diameter of 0.15 mm, while sutures having the sameUSP size designation but made of a synthetic absorbable material or anon-absorbable material will each have a diameter of 0.1 mm. Theselection of suture size for a particular purpose depends upon factorssuch as the nature of the tissue to be sutured and the importance ofcosmetic concerns; while smaller sutures may be more easily manipulatedthrough tight surgical sites and are associated with less scarring, thetensile strength of a suture manufactured from a given material tends todecrease with decreasing size. It is to be understood that the suturesand methods of manufacturing sutures disclosed herein are suited to avariety of diameters, including without limitation 7, 6, 5, 4, 3, 2, 1,0, 1-0, 2-0, 3-0, 4-0, 5-0, 6-0, 7-0, 8-0, 9-0, 10-0 and 11-0.

“Needle attachment” refers to the attachment of a needle to a suturerequiring same for deployment into tissue, and can include methods suchas crimping, swaging, using adhesives, and so forth. The point ofattachment of the suture to the needle is known as the swage.

“Suture needle” refers to needles used to deploy sutures into tissue,which come in many different shapes, forms and compositions. There aretwo main types of needles, traumatic needles and atraumatic needles.Traumatic needles have channels or drilled ends (that is, holes or eyes)and are supplied separate from the suture thread and are threaded onsite. Atraumatic needles are eyeless and are attached to the suture atthe factory by swaging whereby the suture material is inserted into achannel at the blunt end of the needle which is then deformed to a finalshape to hold the suture and needle together. In the traumatic needlethe thread comes out of the needle's hole on both sides and often thesuture rips the tissues to a certain extent as it passes through. Mostmodern sutures are swaged atraumatic needles. Atraumatic needles may bepermanently swaged to the suture or may be designed to come off thesuture with a sharp straight tug. These “pop-offs” are commonly used forinterrupted sutures, where each suture is only passed once and thentied.

Suture needles may also be classified according to their point geometry.For example, needles may be (i) “tapered” whereby the needle body isround and tapers smoothly to a point; (ii) “cutting” whereby the needlebody is triangular and has sharpened cutting edge on the inside; (iii)“reverse cutting” whereby the cutting edge is on the outside; (iv)“trocar point” or “tapercut” whereby the needle body is round andtapered, but ends in a small triangular cutting point; (v) “blunt”points for sewing friable tissues; (vi) “side cutting” or “spatulapoints” whereby the needle is flat on top and bottom with a cutting edgealong the front to one side (these are typically used for eye surgery).

Suture needles may also be of several shapes including, (i) straight,(ii) half curved or ski, (iii) ¼ circle, (iv) ⅜ circle, (v) ½ circle,(vi) ⅝ circle, (v) and compound curve.

Suturing needles are described, for example, in U.S. Pat. Nos. 6,322,581and 6,214,030 (Mani, Inc., Japan); and U.S. Pat. No. 5,464,422 (W. L.Gore, Newark, Del.); and U.S. Pat. Nos. 5,941,899; 5,425,746; 5,306,288and 5,156,615 (US Surgical Corp., Norwalk, Conn.); and U.S. Pat. No.5,312,422 (Linvatec Corp., Largo, Fla.); and U.S. Pat. No. 7,063,716(Tyco Healthcare, North Haven, Conn.). Other suturing needles aredescribed, for example, in U.S. Pat. Nos. 6,129,741; 5,897,572;5,676,675; and 5,693,072. The sutures described herein may be deployedwith a variety of needle types (including without limitation curved,straight, long, short, micro, and so forth), needle cutting surfaces(including without limitation, cutting, tapered, and so forth), andneedle attachment techniques (including without limitation, drilled end,crimped, and so forth).

“Needle diameter” refers to the diameter of a suture deployment needleat the widest point of that needle. While the term “diameter” is oftenassociated with a circular periphery, it is to be understood herein toindicate a cross-sectional dimension associated with a periphery of anyshape.

“Wound closure” refers to a surgical procedure for closing of a wound.An injury, especially one in which the skin or another external orinternal surface is cut, torn, pierced, or otherwise broken is known asa wound. A wound commonly occurs when the integrity of any tissue iscompromised (e.g., skin breaks or burns, muscle tears, or bonefractures). A wound may be caused by an act, such as a gunshot, fall, orsurgical procedure; by an infectious disease; or by an underlyingmedical condition. Surgical wound closure facilitates the biologicalevent of healing by joining, or closely approximating, the edges ofthose wounds where the tissue has been torn, cut, or otherwiseseparated. Surgical wound closure directly apposes or approximates thetissue layers, which serves to minimize the volume new tissue formationrequired to bridge the gap between the two edges of the wound. Closurecan serve both functional and aesthetic purposes. These purposes includeelimination of dead space by approximating the subcutaneous tissues,minimization of scar formation by careful epidermal alignment, andavoidance of a depressed scar by precise eversion of skin edges.

“Tissue elevation procedure” refers to a surgical procedure forrepositioning tissue from a lower elevation to a higher elevation (i.e.,moving the tissue in a direction opposite to the direction of gravity).The retaining ligaments of the face support facial soft tissue in thenormal anatomic position. However, with age, gravitational effectsachieve a downward pull on this tissue and the underlying ligaments, andfat descends into the plane between the superficial and deep facialfascia, thus allowing facial tissue to sag. Face-lift procedures aredesigned to lift these sagging tissues, and are one example of a moregeneral class of medical procedure known as a tissue elevationprocedure. More generally, a tissue elevation procedure reverses theappearance change that results from gravitation effects over time, andother temporal effects that cause tissue to sag, such as geneticeffects. It should be noted that tissue can also be repositioned withoutelevation; in some procedures tissues are repositioned laterally (awayfrom the midline), medially (towards the midline) or inferiorly(lowered) in order to restore symmetry (i.e. repositioned such that theleft and right sides of the body “match”).

“Medical device” or “implant” refers to any object placed in the bodyfor the purpose of restoring physiological function,reducing/alleviating symptoms associated with disease, and/orrepairing/replacing damaged or diseased organs and tissues. Whilenormally composed of biologically compatible synthetic materials (e.g.,medical-grade stainless steel, titanium and other metals: polymers suchas polyurethane, silicon, PLA, PLGA and other materials) that areexogenous, some medical devices and implants include materials derivedfrom animals (e.g., “xenografts” such as whole animal organs; animaltissues such as heart valves; naturally occurring or chemically-modifiedmolecules such as collagen, hyaluronic acid, proteins, carbohydrates andothers), human donors (e.g., “allografts” such as whole organs; tissuessuch as bone grafts, skin grafts and others), or from the patientsthemselves (e.g., “autografts” such as saphenous vein grafts, skingrafts, tendon/ligament/muscle transplants). Medical devices that can beused in procedures in conjunction with the present invention include,but are not restricted to, orthopaedic implants (artificial joints,ligaments and tendons; screws, plates, and other implantable hardware),dental implants, intravascular implants (arterial and venous vascularbypass grafts, hemodialysis access grafts; both autologous andsynthetic), skin grafts (autologous, synthetic), tubes, drains,implantable tissue bulking agents, pumps, shunts, sealants, surgicalmeshes (e.g., hernia repair meshes, tissue scaffolds), fistulatreatments, spinal implants (e.g., artificial intervertebral discs,spinal fusion devices, etc.) and the like.

As discussed above, the present invention provides compositions,configurations, methods of manufacturing and methods of usingself-retaining systems in surgical procedures which greatly increasetheir ability to anchor into the surrounding tissue to provide superiorholding strength and improve clinical performance.

Referring now to the drawings, wherein like reference numerals designatecorresponding or similar elements throughout the several views, FIG. 1shows a front view of the first embodiment of the present invention. Thefirst embodiment of the present invention includes a length of suture 10and having a first section 12, a second section 14 and an interveningsection 16. The length of suture 10 has an elongated body 11 and freeends 13 and 15. The first section 12 has free end 13 and a plurality offirst retainers 18 extending from the periphery of the length of thefirst section in a first direction, indicated by arrow 20. The arrow 20indicates the direction in which the suture is pulled to cause theretainers to flex outwardly The second section 14 has free end 15 and aplurality of second retainers 22 extending from the periphery of thelength of the second section in a second direction, indicated by arrow24. The second direction is opposed to the first direction. Both thefirst retainers 18 and the second retainers 22 face the interveningsection 16 and thus each other. The intervening section 16 has noretainers thereon.

FIGS. 2A and 2B show a suture insertion device 26 of the presentinvention. FIG. 3 shows the suture insertion device assembled with alength of self-retaining suture 10 of the embodiment shown in FIG. 1. Asshown in FIGS. 2A and 2B, the device 26 includes a relatively straightneedle body 25 having a pointed first device end 28, a second device end30 and a length 32. A protective cover 21 covers the pointed end 28 toprevent needle sticks. A recess 34 is located proximate to the firstdevice end 28. The recess 34 is for receiving a cross-sectional portionof the intervening section 16. Thus the recess 34 must be sizedappropriately to accommodate the diameter of the suture 10. It shouldalso be noted that the intervening section 16 must be of sufficientlength so as to enable the intervening length to properly rest withinthe recess 34 without the first 12 or second sections 14 of retainersextending therein. The first suture insertion device end 28 alsoincludes a forwardly facing finger 36. The finger 36 serves to hold thecross-section of the intervening section 16 during insertion into a bodyof a mammal, as discussed in more detail below. The length and diameterof the finger 36 will vary depending upon the suture insertion device 26size and the suture 10 diameter. The device 26 also includes arearwardly extending member 29 adjacent to the first device end 28. Therearwardly extending member 29 also serves to hold the suture within therecess during forward movement of the device 26. The length of thesuture insertion device 26 opposed to the recess 36, is the underside38. The underside 38 of the suture insertion device is sharpened so thatit may easily cut an insertion pathway as the suture insertion device 26is inserted into the body of a mammal, as will be discussed in moredetail below. A handle 31 is located proximate and fixed to the seconddevice end 30. The handle 31 serves as a holding point for the userduring use. The handle 31 includes a handle body 33 having a length anda suture holding channel 35 extending along the side of the handle alongits length. The suture holding channel 35 is sized to receive a lengthof suture of the present invention during use, which will be discussedin detail below.

In use, the assembly of the suture length 10 and suture insertion device26 are designed to be inserted into the body of a mammal. This proceduremay be for the purpose of binding a wound, closing an incision orendoscopic port. Such that, when the length of suture is received withinthe recess 34 the intervening section 16 is relatively perpendicular tothe suture insertion device length 32 at that point, as shown in FIG. 3.FIG. 4 also shows an enlarged view of the cross-section of theintervening section 16 of the length of suture 10 received into therecess 34 of the suture insertion device 26. After the protective cover21 is removed from the first end 28 of the suture insertion device 26,it is then inserted into a section of the body of the mammal, typicallywithin a section of tissue that will provide support for the first 18and second retainers 22 upon removal of the suture insertion device,such as a section of muscle. As the suture insertion device 26 moves ina forwardly direction, the device holds the length of suture 10 withinits recess 34. The finger 36 helps to hold the intervening section 16within the recess 34 during forward travel of the device 26. Thesharpened underside 28 of the device 26 cuts through the mammaliantissue to form an insertion pathway 40. In addition, as the length ofsuture 10 moves in a forwardly direction, the first 18 and second 22retainers flex and remain close to the perimeter of the suture body 11.When the first 12 and second 14 sections of the suture length 10 havebeen completely inserted into the body of a mammal, the user stops theforward travel of the device 26. The user then begins to remove thedevice 26 by moving the device in a direction substantially opposed tothe insertion pathway. As this occurs, the opposed movement of thedevice 26 enables the intervening section 16 to free itself from itslocation within the recess 34. The finger 36 no longer is able to holdthe intervening section 16 within the recess 34 when the device 26travels in an opposite direction from the insertion pathway. As aresult, the intervening section 16 is freed from its position within therecess 34, and the device 26 may be completely removed from the tissueof the mammal by reversing the direction taken on the insertion pathway.At this time any movement of the suture length 10 in a direction opposedto the insertion pathway would result in the first 18 and second 22retainers becoming rigid and opposing movement in a direction opposed tothe insertion pathway by extending outwardly relative to the peripheryof the suture body 11 and into the surrounding body of the mammal tosecure the position of the first 12 or second 14 section at thatlocation.

In the situation where a wound is being repaired or an incision is beingclosed, this method would further involve joining the length of suturewith a second length of suture similarly inserted into the body of amammal at an alternative location. The free ends of each length ofsuture would then be tied or joined in an appropriate fashion tocomplete the closure of the wound or incision.

In the case where the length of suture is inserted for the purpose ofsupporting a body part, such as a bladder neck, and other pelvic floorprolapsed conditions, the length of suture would be joined to at leastone other length of suture similarly inserted into the body where thefree ends would remain proximate to the body part to be supported. Thepart would be supported by joining the free ends of the lengths ofsuture 10 under the body part so as to form a sling or similar supportmember to ensure that the lengths of suture will prevent the body partfrom any further movement. Such ends may also be joined to a singlepiece of mesh or other material conductive to prolonged contact with theparticular body part being suspended.

It is further anticipated that the free ends of the suture may be joinedwith a drug delivery agent, such as a chemotherapeutic agent for theprecise localized delivery of chemotherapeutic drug to cancerous tissuessuch as in the prostrate and in tuomor growths in other variouslocations. It is also anticipated that the suture may be attached to atacking device for use in connection with mesh that is used in herniarepair. The tacks are used to hold the mesh in repairing herniatedtissue while providing a profile that is less palpable to the patient.It is further anticipated that the suture may be attached to a markerfor use in radiation therapy. It is anticipated that the suture may alsobe attached to a radio labeled tag for the identification of tissue inx-rays.

It should be stressed that the advantage of the present invention overthe prior art provides a greater level of accuracy in fixing theseitems, such as markers, tags, tacks or therapeutic and drug deliveryagents or the like to the self-retaining suture because the exactlocation of the item can be achieved by the needle or suture insertiondevice. With these items fixed to the suture, the surgeon or othermedical professional can place the item in the precise location neededin the patient's body to provide maximum efficacy and can retrieve theneedle or insertion device with no movement by the suture or theattachment because of the retainered configuration.

It is anticipated that the free ends of the length of suture 10 mayinclude an attachment loop 41 or other attachment means for fixing anobject to the suture, as shown in FIG. 1A. This may be done ahead oftime to securely fix an object, such as a tack, marker, therapeutic orchemotherapeutic agent to the suture length for insertion into a patientrather than making the attachment at the time of the procedure. Thisattachment ahead of time results in a more secure attachment and thus amore accurate placement since it is less likely that the object attachedwill move or the attachment means will fail.

In addition, because the attached items are inserted into the body bymeans of a suture that is inserted to the desired location and thenreversed, the insertion device or needle does not create a furtherpathway through the tissue. This results in further assuring that thesuture remains in its intended location because there is no furtherpathway for the suture to migrate. In some cases, standard suture maymigrate along an insertion pathway if that pathway is cut or ripped orotherwise disrupted. In the present case, because the sutures areretainered and the suture and attachment are inserted using a detachableneedle or insertion device, no further insertion pathway is created.Thus, potential migration of the suture and attachment are significantlyprevented.

Also, because the insertion occurs only to the point of placement,neighboring tissue located beyond the placement point, is not disruptedand thus, damage to the surrounding tissue area is prevented. Thisresults in minimal pain and exposure to infection for the patient. Thisalso results in a higher success rate as complications resulting fromsurrounding tissue damage are eliminated.

In cases of chemotherapy delivered locally, it is critical to thesuccess of the delivery of the chemotherapeutic drug that the drugdelivery agent be located as close as possible to or at a specific sitewithin the tumor being treated. With this assembly, the surgeon candeliver with fine accuracy the agent or item to the desired location anda reduced risk to adjacent normal tissue. This enables the drug agent towork at its maximum potential without loss of efficacy due to migrationof the drug agent. Furthermore, in situations where markers are used forradiation therapy or the like, the greater the accuracy and localizedplacement of the marker, the more focused the radiation therapy on aparticular location will be. In cases of using the suture assembly ofthe present invention with tacks in hernia repair, the repair procedurewill have a higher success rate, if the tacks are anchored in such a wayas to reduce migration. The present invention will provide sufficientreduction in migration as well as accurate placement of the tacks forsuch a procedure. Further, the present invention minimizes the profileof the tack overall, a favorable improvement over current larger tackingdevices that are often palpable to the patient and thus a cause ofpatient distress.

It should be further noted that the attachments to the suture discussedabove are equally applicable to the remaining embodiments that will bediscussed in more detail below. In some cases, an alternative embodimentmay provide greater attachment capability than the first embodimentdiscussed above. For instance, the embodiments having a continuous loopof suture may be more appropriately suited to the affixation of a markeror therapeutic agent than the single length which requires manualattachment.

Testing of First Embodiment of the Present Invention

Applicants have conducted tests relating to the self-retaining sutureassembly described above. The tests were designed to determine the pullstrength required to remove the self-retaining suture length of thefirst embodiment of the present invention from within a test sample ofmammalian tissue. A total of 62 threads were tested. Some of the suturelengths were swedged onto a standard surgical needle. The standardsurgical needle had a diameter of 0.68 mm. Other suture lengths wereplaced within the recess of the suture insertion device of the presentinvention as shown in FIGS. 2A and 2B. The diameter of the needle of thepresent invention was 0.70 mm. Another variable in the suture insertiondevice design was the curvature. Some of the samples tested had thesuture length inserted by means of an attached needle and some of thesamples tested had the suture length inserted by means of a detachablesuture insertion device.

The term “attached” means that the needle was physically tied to thesuture and detachment from the suture was accomplished by cutting thesuture away from the needle. The term “detachable” means that the sutureinsertion device was designed in accordance with the embodimentdiscussed above. Each detachable suture insertion device had a recessfor receiving a portion of the intervening length of the suture.

Some of the attached needles and some of the detachable suture insertiondevices were straight and some of the attached needles and detachablesuture insertion devices were curved. The attached needles were 0.70 mmin diameter and the detachable suture insertion devices had a diameterof 0.68 mm. It should be noted that the attached needle diameter cannotbe made any smaller due to the present state of manufacture. Theattached needle diameter must be of a minimum diameter to provide forthe boring of its end to a sufficient clearance to receive the threadwhile retaining enough unbored perimeter to enable the perimeter to beswedged or crimped onto the suture body. At present, if the sutureinsertion device diameter is less than 0.70 mm, it will not provide asufficient bore to allow the insertion of the diameter of the threadthat was tested. This presents a further advantage of the presentinvention. Detached suture insertion devices of the present inventionmay be made smaller in diameter than currently available attachedneedles. This results in a less invasive procedure and may enable theself-retaining suture to grip the surrounding tissue more effectivelysince a narrower insertion pathway permits the retainers to make contactwith the surrounding tissue with less flexure of the retainer. It shouldbe further noted that a smaller diameter suture insertion device enablesthe use of a smaller diameter suture. These relative dimensions havebeen previously optimized in the cited prior art of Table 1.

The curved needles and suture insertion devices tested had a radius ofcurvature of 180°/30 mm. The lengths of the attached needles anddetached suture insertion devices were 50 mm. Both the attached straightand curved needles were made of surgical grade stainless steel and weremade by B. G. Sulzle, Inc of Syracuse, N.Y. The detachable curved andstraight suture insertion devices were made of stainless steel and weremade by Prym-Dritz Corporation of Spartenburg, S.C.

The suture material was USP #1 black monofilament nylon supplied byAshaway having a diameter of 0.433 mm. The suture length was 38 cm. Theretainer dimensions were 1.0 mm in length, 0.16 mm in depth and theangle from the longitudinal axis was 27°. In addition, the retainerswere arrayed in a helical pattern with one retainer being located every1 mm. The retainer pattern completed 360° of rotation around thecircumference of the suture for each 8 mm of suture length.

In addition, there were three types of suture arrangements used in thetesting. The first group was standard suture having no retainers at all.This group is described as “0×0”. The second group had retainers on oneside of the suture only (referred to as “1×0”). The third group hadretainers on both sides of the suture length (referred to as “1×1”). Inthe second and third groups, a single section of retainers had a lengthof 3.5 cm. In the case of the third group, the space between facingretainers was 5 mm. A diagram of the retainer configuration for thethird group is shown in FIG. 5.

The test samples were pork shoulder segments cut into rectangular stripshaving the following dimensions: 3 cm wide, 10 cm long and 4 cm thick.The tissue had no skin and consisted essentially of muscle with varyingamounts of fat and fascia. This tissue is considered to be similar instructure/performance to that of soft tissue located in the pelvic floorand in other areas of the human body, such as where access ports aremade for endoscopic procedures. Each tissue sample was marked using aguide to ensure that the self-retaining suture lengths would be fullyinserted in each sample tested. The markings indicated where theself-retaining suture lengths started and ended. The markings werelocated in substantially the lower half of the longitudinal axis of theeach sample. This was done to ensure that each sample had sufficientlength on the upper portion to enable an effective grip by thetensiometer without interfering with the suture length. The suturelengths were inserted into the tissue samples in one of two ways. Forthose inserted with a straight suture insertion device, the sutures wereinserted with the suture insertion device at approximately the centerpoint at one end and moved along the longitudinal axis of the tissuesample until all of the retainered section of the suture length wasbetween the marking. For those test samples having an attached sutureinsertion device, the suture insertion device was moved through thetissue sample length along the longitudinal axis. Once the retaineredsections were located between the markings, the suture insertion devicewas moved out of the tissue and severed from the suture.

For the tissue samples using a curved suture insertion device, thesuture insertion device was inserted through a side of the tissue sampleand moved along a curved insertion pathway. The curved insertion pathwaysamples were located approximately one-third of the length of thesample. Further, the samples that were threaded with needles having thesuture attached thereto were moved through the insertion pathway. Oncethe full length of the self-retaining suture segment was containedwithin the tissue, the needle was guided outward from the tissue. Oncethe needle was cleared from the tissue, the suture was cut from theneedle prior to testing.

The pull tests were performed by a Test Resources Universal TesterTensiometer, model 200Q. The free ends of the suture length wereattached between two sides of the bottom vice grip. The top of thetissue strip was attached between two sides of the top vice grip whichhad serrated surfaces on each side to achieve greater gripping strengthon the sample. Care was taken to ensure that the portion of the tissuecontaining the suture was not held within the top vice grip. Thetensiometer was operated at a rate of 10 inches per minute until eitherthe suture broke or until the suture was pulled from the tissue sample.The tensiometer displayed the maximum pull-out force at the time offailure or pull out. A total of 62 threads were tested including thoseinserted by attached needles and detachable suture insertion devices,with one exception. The detachable suture insertion devices were theonly type able to deliver the self-retaining suture segments havingretainered portions on both sides of the length (e.g. the 1×1 segments).Of the 62 threads tested, 56 samples resulted in the sutures beingpulled from the tissue, 4 samples resulted in thread breakage, and 2resulted in the tissue segment pulling away from the top vice grip ofthe tensiometer prior to suture pull out or breakage. The maximum pullstrength recorded for each sample, in ounces, is set forth below inTable 2

Data In Ounces Type Needle Type Pattern 1 2 3 4 5 6 7 Average 0x0attached Straight 0.5 0.6 0.6 0.8 0.5 n/a n/a 0.6 0x0 detached Straight2.4 2.2 1.9 2.2 2.2 n/a n/a 2.2 0x0 attached Curved 0.6 0.8 0.6 0.6 0.6n/a n/a 0.7 0x0 detached Curved 2.7 2.6 5.4 2.6 2.1 n/a n/a 3.1 1x0attached Straight 17.3 37.0 30.6 23.8 17.0 (B) 43.4 49.9 31.3 1x0detached Straight 33.9 56.3 34.7 37.9 25.3 32.3 33.1 36.2 1x1 detachedStraight 43.2 31.2 35.8 25.3 52.8 29.9 26.7 35.0 1x0 attached Curved39.7 (B) 31.0 (B) 46.4 53.0 (B) 37.4 42.7 43.5 42.0 1x0 detached Curved26.6 39.4 32.8 41.0 48.8 45.8 35.4 38.5 1x1 detached Curved 43.4 67.466.6 55.0 65.4 (T) 34.2 67.7 (T) 57.1 Notes: (B) Thread Broke (T) Tissueseparated from tensionmeter claspFIG. 17 is a table that provides a comparative analysis regarding thepullout strength in ounces of each suture tested. The sutures aregrouped into sample groups. The table indicates the average pull outstrength of sutures with straight vs. curved insertion pathways, as wellas those with attached needles and those using the suture insertiondevice of the present invention. Further, the table assesses the averagepull strength of the different sutures having none, one or two sectionswith retainers thereon. As can be seen from the data in Table 3, thesutures having a curved pathway with both sections of the suture lengthhaving retainers thereon and having been inserted with the sutureinsertion device of the present invention, demonstrated the highestlevel of pull out strength. All test groups inserted with the sutureinsertion device of the present invention demonstrated at leastequivalent holding strength when compared with sutures with similarretainer patterns that were delivered with an attached needle.

ALTERNATIVE EMBODIMENTS OF THE PRESENT INVENTION

FIG. 6 shows a first alternative embodiment to the present invention ofFIG. 1. FIG. 6 includes a length of suture 42 having a first end 44 anda second end 46. A loop 48 is located at the first end 44 of the length42. A plurality of retainers 50 extend along the periphery of the lengthof suture 42. All of the retainers 50 face the loop 48. The loop 48 isrelatively small relative to the length of suture 42.

In use, the cross-section of the loop 48 is received into the recess 34of the suture insertion device 26 discussed in detail above. The sutureinsertion device 26 is inserted into a section of a body of a mammal. Asdiscussed previously, it is preferable to insert the suture insertiondevice 26 with the suture 42 into a section of muscle so that theretainers 50 are better able to grab the muscle tissue and hold thesuture 42 in place. Conversely, the insertion of the suture into an areaof fat will not enable the retainers to effectively bind themselves tothe surrounding fat and thus not enable the suture to be effective inits ability to bind a wound or support an organ or the like. Once thesuture insertion device 26 is inserted into the tissue of a mammal, thefinger 36 of the device holds the loop 48 within the recess 34 duringforward travel of the device within the body. When the length of suturedesired is fully inserted within the body of a mammal, the user stopsthe forward travel of the suture insertion device 26. The user removesthe device 26 from the body by reversing the forward travel of thedevice. This results in a release of the loop 48 from its positionwithin the recess 34 and enables the device to be completely removedfrom the body while enabling the length of suture 42 to remain inposition within the body. During insertion of the suture length, theretainers 50 of the suture 42 flex towards the suture length.Conversely, if the length of suture 42 were pulled in a directionopposed to the insertion direction, the retainers 50 would become rigidand flex outwardly and resist movement in the opposed direction.

FIG. 7 of the present invention displays a further alternative to thepresent invention. This alternative includes a length of suture wherethe ends have been joined to form a second alternative looped suture 52.The loop 52 has an elongated second alternative length 54 that isgenerally circular in cross section. The loop 52 includes a first half56 and a second half 58 and a second alternative intervening section 60.The intervening section 60 is located between the first 56 and second 58halves. The first half 56 has a plurality of first half retainers 62extending from the periphery of the length of the first half in a firstdirection, indicated by the arrow 64. Similarly, the second half 58 hasa plurality of second half retainers 66 extending from the periphery ofthe length of the second half in a second direction, indicated by thearrow 68. The second direction is opposed to the first direction. Boththe first half retainers 62 and the second half retainers 66 face thesecond alternative intervening section 60 and thus each other. In thepresent embodiment, there also exists empty loop space 70 located at thedivergence of the first half retainers 62 and second half retainers 66.The empty loop space 70 may be used as a support for an organ or otherbody part when in use.

In use, the assembly of the looped suture 52 and suture insertion device26 are designed to be inserted into the body of a mammal. This proceduremay be for the purpose of binding a wound, closing an incision orattaching an object such as a surgical tack, implant, marker orchemotherapeutic agent. FIGS. 7A and 7B show proposed uses of theembodiment shown in FIG. 7. Because the present invention provides forthe effective and accurate anchoring of a length of suture withinmammalian tissue, it is anticipated that such self-retaining suturelengths or loops may be used to fix objects within tissue as well. Asdiscussed above with respect to previous embodiments, the self-retainingsuture embodiment of FIG. 7 may be used to effectively fix achemotherapeutic agent into the body of a mammal, as shown in FIG. 7A.The chemotherapeutic agent 190 is embedded within a polymer resinstructure 192 and attached to the empty loop space 70 of the secondalternative looped structure 52. The chemotherapeutic agent 190 isdesigned to be controllably released into the mammal's body at aspecific rate.

FIG. 7B shows the second alternative looped structure 52 of FIG. 7 witha surgical tack 194 attached to the empty loop space 70. The tacks areused primarily in hernia procedures as discussed in detail above. Thelooped configuration of the second alternative looped structure 52 maybe more suited to attachment of objects as the loop is a closedstructure and there is less opportunity for the object to disconnect orbreak away from the loop structure than a length of suture with anobject manually attached as described above. It should be noted that theembodiments of FIGS. 7A and 7B could also be used with a single lengthof suture 42 as shown in FIG. 6, or with a length of convergingretainers as shown in FIG. 1A and discussed in detail above.

The embodiments of FIGS. 6 and 7 are also applicable for use inanchoring a seroma evacuation tube assembly 222, as shown in FIG. 7C.Typically, such a tube is placed at the end of a procedure, such as anendoscopic procedure, within the wound to allow any pockets of fluidthat may form to drain. The tube assembly 222 has a first end (notshown) which is positioned within the incision, or existing pocket offluid. It should be noted that the located of the first end is extremelyimportant. If the first end is placed too shallow, it will not makesufficient contact with the fluid pocket and be able to effectivelydrain it. If the first end is placed too deeply, it will surpass thefluid pocket and make contact with the surrounding tissue and will notbe effective in draining the seroma. Tube assembly also has a second end226 that is opposed to the first end and is located at the surface ofthe skin 228. A pair of opposing tabs 230 extend from the second end 226in opposed directions to form a platform to secure the tube assembly222. Once secure, the tabs 230 help to maintain a fixed position for thetube assembly 222. Each tab 230 has an anchoring hole 232. Eachanchoring hole is used to secure the tube assembly 222 to the skinsurface 228. This is done by placing a few sutures or stitches in theskin surface 228 to effectively secure the position of the tube assemblyrelative to the skin surface. With the present invention, the securingof the tube assembly 222 to the skin surface can be accomplished quicklyand easily. The user inserts either a suture length 42 (as shown in FIG.6) or a second alternative loop suture (as shown in FIG. 7) into theanchoring hole 232 using the suture insertion device 26. Once a portionof the length or loop is embedded into the tissue, the suture insertiondevice 26 is retrieved leaving a length of self-retaining suture withinthe tissue. Once the suture is fixed to the tube assembly 222, iteffectively anchors the tube assembly in place. This procedure is animprovement over the prior art in that the anchoring method may beaccomplished by someone other than a doctor, such as a nurse or medicaltechnician. Furthermore, because the anchoring method of the presentinvention does not require any movement of the tube assembly 222 duringsuturing, it is an appropriate application for this procedure. Theabsence of having to tie off the suture or move the needle in and outduring suturing enables the medical professional to quickly andaccurately secure the tube assembly 222 into place with minimum pain tothe patient and little or no movement of the tube assembly during theprocess.

FIG. 8 shows a further alternative embodiment of the present invention.FIG. 8 shows a first alternative looped suture 74 having a firstalternative loop half 76 and a second alternative loop half 78. Thefirst alternative loop half 76 includes a first alternative section 80,a second alternative section 82 an intermediate section 83 in betweenthe first 80 and second 82 alternative sections. The first alternativesection 80 has first alternative retainers 84 extending from the suture74 in a first direction shown by arrow 86. The second alternativesection 82 has second alternative section retainers 88 extendingtherefrom in a second direction shown by arrow 90. The first 84 andsecond 88 alternative section retainers both face the intermediatesection 83 and thus each other.

The second alternative loop half 78 is similarly structured to the firstalternative loop half 76. The second half 78 includes a third section92, a fourth section 94 and a second intermediate section 96. The secondintermediate section 96 is located between the third 92 and fourth 94sections. The third section 92 has a plurality of third retainers 98extending from the periphery of the length of the third section in thesecond direction, indicated by arrow 90. Similarly, the fourth section94 has a plurality of fourth retainers 100 extending from the peripheryof the length of the fourth section in a first direction, indicated byarrow 86. Because the first and second directions are opposed, asdiscussed above, the third retainers 98 and the fourth retainers 100face the second intermediate section 96 and thus each other. The spacesbetween the first alternative loop half 76 and the second alternativeloop half 78 is first alternative empty loop space 102 and has noretainers thereon.

The embodiment of FIG. 8 is shown in FIG. 9 with a mesh sling 91attached thereto. This enables the assembly of FIG. 11 to support anobject such as a bladder neck without cutting into the tissue and alsoeffectively distributing the support load across the sling.

In use as a support for an object, such as the suspension of a bladderneck, the suture insertion device 26 receives a portion of the firstintermediate section 83 within its recess 34. The first alternativeempty loop space 102 and the mesh sling 91 attached thereto between thefirst alternative loop half 76 and the second alternative loop half islocated under a body part 72 to be supported, such as the bladder neck,as shown diagrammatically in FIG. 11. It should be noted that the sling91 may be looped over the empty loop space or it may be fixed thereto.The user places the intermediate section 83 within the recess 34 of thesuture insertion device 26. The suture insertion device 26 is theninserted into a section of the body of the mammal, typically within asection of tissue that will provide support for the first alternativelooped suture 74 upon removal of the suture insertion device, such as asection of muscle. As the suture insertion device 26 moves in aforwardly direction, the finger 36 helps to hold the first alternativelooped suture within the recess 34 during forward travel of the sutureinsertion device. The sharpened underside 38 of the suture insertiondevice 26 cuts through the mammalian tissue to form an insertionpathway. In addition, as the first alternative looped suture 74 moves ina forwardly direction, the first alternative retainers 84 and secondalternative retainers 88 retainers flex and remain close to theperimeter of the first alternative looped suture. When the firstalternative retainers 84 and the second alternative retainers 88 of thefirst alternative looped suture 74 have been completely inserted intothe section of tissue, the user stops the forward travel of the sutureinsertion device 26. The user then begins to remove the suture insertiondevice 26 by moving the suture insertion device in a direction opposedto the insertion pathway. As this occurs, the opposed movement of thesuture insertion device 26 enables the first alternative looped suture74 to free itself from its location within the recess 34. The finger 36no longer is able to hold the intermediate section 83 within the recess34 when the suture insertion device 26 travels in an opposite directionfrom the insertion pathway. As a result, the intermediate section 83 isfreed from its position within the recess 34, and the suture insertiondevice 26 may be completely removed from the tissue of the mammal byreversing the direction taken on the insertion pathway. At this time anymovement of the first alternative loop half 76 in a direction opposed tothe insertion pathway would result in the first alternative retainers 84and the second alternative retainers 88 becoming rigid and opposingmovement in a direction opposed to the insertion pathway. This alsoresults in the first alternative retainers 84 and second alternativeretainers 88 extending outwardly relative to the periphery of the firstalternative looped suture 74 and into the surrounding body of the mammalto secure the position of the suture at that location.

Once the suture insertion device 26 is removed from the body of themammal, the suture insertion device is then used to insert the secondalternative loop half 78 of the first alternative looped suture 74within the body of the mammal. As discussed above, the position of thefirst alternative empty loop space 102 and mesh sling 91, between thefirst alternative loop half 76 and the second alternative loop half 78,are checked to ensure that they remain located under the bladder neck toprovide support. Thus, with the first alternative loop half 76 alreadyinserted, the user, typically a surgeon or other medical professional,would insert the second alternative loop half 78 into an alternativesection of tissue that would be able to provide effective support to theorgan. This is accomplished by inserting both halves of the firstalternative looped suture 74 at particular locations and angles withinthe mammalian tissue, such that when both halves of the firstalternative looped suture 74 are completely inserted, would support andhold the organ in a position or location as medically or surgicallydesired. FIG. 11 provides a diagrammatic depiction of such anarrangement where the body part 72 is supported by the two halves of thefirst alternative looped suture 74.

The insertion of the second alternative loop half 78 of the firstalternative looped suture 74 is similar in many respects to the stepstaken to insert the first alternative loop half 76. To insert the secondalternative loop half 78, the user places the second intermediatesection 96 within the suture insertion device recess 34 and inserts thesuture insertion device 26 into the body of a mammal at the appropriatelocation and angle relative to the insertion pathway taken with thefirst alternative loop half 76 to ensure that the subject body part willbe supported when the second alternative loop half 78 is fully inserted.Similarly, as discussed above, the user inserts the suture insertiondevice 26 into a section of the body of the mammal, typically within asection of tissue, such as a section of muscle. As the suture insertiondevice 26 moves in a forwardly direction, the suture insertion deviceholds the second alternative looped half 78 within its recess 34 at thesecond intermediate section 96. The finger 36 helps to hold the secondintermediate section 96 within the recess 34 during forward travel ofthe suture insertion device 26. The sharpened underside 38 of the sutureinsertion device 26 cuts through the mammalian tissue to form a secondinsertion pathway. During insertion, the third 98 and fourth 100retainers flex inwardly toward the periphery of the first alternativelooped suture 74 so as to ease forward movement of the suture insertiondevice 26. When the second alternative loop half 78 has been completelyinserted into the selected section of muscle, the user stops the forwardtravel of the suture insertion device 26. The user then begins to removethe suture insertion device 26 by moving it in a direction opposed tothe second insertion pathway. As this occurs, the opposed movement ofthe suture insertion device 26 enables the second intermediate section96 to free itself from its location within the recess 34. The finger 36is no longer able to hold onto the second intermediate section 96 withinthe recess 34 when the suture insertion device 26 travels in an oppositedirection from the second insertion pathway. As a result, the secondalternative loop half 78 is freed from its position within the recess34, and the suture insertion device 26 may be completely removed fromthe tissue of the mammal by reversing the direction taken on the secondinsertion pathway. This also results in the third 98 and fourth 100retainers extending outwardly relative to the periphery of the firstalternative looped suture 74 and into the surrounding body of the mammalto secure the position of the second alternative loop half 78 at thatlocation.

Once the first alternative loop half 76 and second alternative loop half78 of the first alternative looped suture 74 have been inserted into thebody of a mammal, the first alternative empty loop space 102 between thefirst 76 and second 78 halves should be taught and properly positionedunder the body part 72 to be supported, as shown in FIG. 11. Any reversemovement of the suture length 10 along the first alternative loop half76 would result in the first alternative 84 and second alternative 88retainers becoming rigid and opposing movement in a direction opposed tothe first insertion pathway. This enables the first alternative loophalf 76 to continue to support the body part 72. Similarly, any reversemovement of the second alternative loop half 78 would result in thethird 98 and fourth 100 retainers becoming rigid and opposing movementin a direction opposed to the second insertion pathway. This enables thesecond alternative loop half 78 to continue to support the body part atthe intended location.

A further alternative use for the embodiment of FIG. 8 is shown in FIGS.10 and 12. FIG. 10 shows the embodiment of FIG. 9 in assembly with thesuture insertion device 26. FIG. 12 shows the use of the looped suture74 used in the closure of an incision 150 made following an endoscopicprocedure. During such a procedure, a relatively small incision is madeat the surface of the body. However, the incision, as can be seen in thefigure, may be relatively deep to provide access to the desired surgicalobjective. Upon completion of the procedure the incision 150 made mustbe effectively closed throughout its full depth in order to prevent theformation of fluid pockets called seromas that can harbor infection. Adeep incision requires suturing at a number of levels of differenttissue. Further, it is often times difficult to properly close thedeepest levels of tissue using present equipment and techniques becauseof insufficient space to manipulate suture needles. As a result, thepresent invention provides a significant advancement in this area.

In closing an endoscopic port closure, the user may use the loop suture74 shown in FIG. 12 and ensure that a portion of the first intermediatesection 83 was received within the recess 34 of the suture insertiondevice 26. In the case of a port closure, the layers of tissue needingclosure may include fascia 152, muscle 154, fat 156, and skin 158. Theincision 150 creates a pair of opposing incision walls, 151, 153.

As can been seen in FIG. 12, the deepest portion of the incision isnarrow. As a result, it is more challenging for a surgeon to effectivelymanipulate the tissue in this area to properly close the incision. Inview of this challenge, it is most effective to use a curved, detachedsuture insertion device in this application rather than a straightsuture insertion device or an attached suture insertion device thatwould require detachment and tying off. It should be noted that wherethere is more space or a different location where the tissue is moreaccessible, a straight suture insertion device or an attached sutureinsertion device may be more effective. The curved suture insertiondevice 27, as shown in FIG. 12A offers the advantage of being able tocreate curved insertion pathways that can easily weave between two sidesof an incision, as shown in FIG. 12 to effectively close all layers oftissue in the incision.

The curved suture insertion device 27, as shown in FIG. 12A, is the samein all respects to the suture insertion device 26 shown in FIGS. 2A, 2Band 4 except that the curved device has a radius of curvature along thesuture insertion device body 25A rather than a straight length. Thus,reference to the suture insertion device recess 34 and the otherfeatures of the suture insertion device will be the same for bothconfigurations where applicable. It should also be noted that the radiusof curvature of the suture insertion device body 25A, like the lengthand diameter, are determined by the application and suture size used.

To initiate the closing of the port closure of FIG. 12, the curvedsuture insertion device 27 is inserted into the deeper tissues, such asthe muscle 152 at point A. The curved suture insertion device is pushedinto the incision wall 153 at point A until at least a portion of thecurved suture insertion device body 25A and the first alternative loophalf 76 held within the recess 34 are embedded in the muscle 154 tissue.At that point, the curved suture insertion device 27 is pivoted towardthe incision as indicated by arrow B so that a portion of the first end28 of the device 27 and the loop half exit the incision wall 153 andreenter incision wall 151. As the user continues to pivot the curvedsuture insertion device 27, a portion of the curved suture insertiondevice body 25A that holds the first alternative loop half 76 is urgedforwardly and becomes embedded in the fascia tissue 152. As discussedabove, the finger 36 helps to hold the first alternative loop half 76within the recess 34 during forward travel of the curved sutureinsertion device 27. Also as discussed above, as the first alternativeloop half 76 moves in a forwardly direction, the first alternativeretainers 84 and second alternative retainers 88 retainers flex andremain close to the perimeter of the first alternative loop half 76.Moreover, as the curved suture insertion device is inserted into theincision wall 153 and rotated therein, it creates a curved insertionpathway 160. Once the surgeon has effectively embedded at least aportion of the first alternative loop half 76 in the fascia tissue 152,forward movement of the curved insertion device and the firstalternative loop half 76 stop at point C in FIG. 12B.

To retrieve the curved suture insertion device 27, the user reverses thetravel along the curved insertion pathway 160. As this occurs, theopposed movement of the curved suture insertion device 27 enables thefirst alternative loop half 76 to free itself from its location withinthe recess 34. The finger 36 no longer is able to hold the intermediatesection 83 within the recess 34. As a result, the intermediate section83 is freed from its position within the recess 34, and the curvedsuture insertion device 27 may be completely retrieved from the incisionwall 153 at the point of entry A. To secure the first loop half 76within the incision and effectively bind the incision walls 151,153together, the user would pull on the embedded first alternative loophalf 76 at the first alternative empty loop space 102 to create tensionin the loop half and pull the incision walls 151, 153 together. At thistime any movement of the first alternative loop half 76 in a directionopposed to the curved insertion pathway 160 would result in the firstalternative retainers 84 and the second alternative retainers 88becoming rigid and opposing movement in a direction opposed to theinsertion pathway. This also results in the first alternative retainers84 and second alternative retainers 88 extending outwardly relative tothe periphery of the first alternative looped half 76 and into thesurrounding body of the tissue to secure the position of the firstalternative loop half 76 at that location.

Once the curved suture insertion device 27 is removed, an attached,curved needle 23 is then used to insert the second alternative loop half78 of the first alternative looped suture 74 to close the remaininglayers of tissue. An attached curved needle 23 is appropriate in thisapplication because the suture pathway for closing the second half ofthe incision is upward, out of the incision where the surgeon will haveadequate space to tie off the suture ends. The attached curved needle 23is fixedly attached to the second intermediate section 96 of the secondalternative loop half 78. It should be noted that the curved sutureinsertion device 23 may also be fixedly attached to two free ends of alength of self-retaining suture rather than a loop end. The function ofthe fixed suture insertion device and self-retaining suture attachedthereto remains the same.

The insertion of the second alternative loop half 78 is similar in manyrespects to the steps taken to insert the first alternative loop half76. The user inserts the curved needle 23 with the second alternativeloop half 78 fixed thereto into the tissue on the opposed side of theincision from the exit point of the first alternative loop half 76 atpoint D in FIG. 12. Similarly with the first insertion of the curvedsuture insertion device 27, the curved suture insertion device 23 isinserted into the incision wall 151 and moved inwardly. Then the curvedsuture insertion device 23 is pivoted so that the first end 28 of thesuture insertion device exits the incision wall 151 and reenters theopposing incision wall 153 at point E. The curved suture insertiondevice 23 is inserted as discussed above into the incision wall 153 andthen pivoted so as to cause the first end 28 to exit the incision wall153 and reenter the opposing wall 151 at point F. Once the curved sutureinsertion device 23 exits the skin 158, the user pulls on the secondalternative loop half 78 so that it is in tension Once the secondalternative loop half 78 is pulled taught, the lengths extending outsidethe skin may be cut back to reduce accidental pulling or catching. Itshould be noted that the second portion of the above closing proceduremay be accomplished with a detached suture insertion device using thesuture of the present invention. Alternatively, a straight sutureinsertion device, attached or detached, may be used in the appropriatecircumstance. The use of curved and straight, and attached and detachedsuture insertion devices will vary depending upon the particularprocedural situation as discussed above.

The above provide examples of several different types of sutureconfigurations that may be used for support of body parts, to bindwounds or close incisions created during surgical procedures. FIG. 13shows a further alternative loop configuration that has multiple loopsections. A multi-sectional looped suture may be used in a number ofdifferent surgical or medical procedures, including the support of anorgan, such as the bladder neck discussed above. It is anticipated thatthe multi-sectional looped suture may also have other applications suchas the support or binding of other body parts, or the binding or closingof wounds or incisions that require a multi-point approach in the repairor procedure. For example, in a wound that has multiple tears or rips, amulti-sectional loop may be an appropriate suture for repair in that itmay be able to pull all sections of the wound together without having toresort to the use of multiple lengths of suture. In addition, oneadvantage of using a multi-sectional looped suture is that theself-retaining sutures are inserted into the tissue below the skin lineand thus pull the tissue or sections of the wound together so that theremay not need to be any sutures on the skin surface. This results in theability to allow the wound to heal without additional sutures on theskin surface which may minimize the chance of further scarring.

FIG. 13 shows a length of suture where the ends are joined to form amulti-sectional loop 104. The multi-sectional loop 104 has threesections 105. Each section 105 has a first length 106, a second length108, and an intermediate length 110. The first length 106 has firstlength retainers 114 extending peripherally from the first length in afirst direction shown by arrow 116. The second length 108 has secondlength retainers 118 extending peripherally from the second length in asecond direction shown by arrow 120 which is opposed to the firstdirection. The first length retainers 114 along the first length 106 andthe second length retainers 118 along the second length 108 face theintermediate length 110 and each other. The empty loop space 112 is thatlength of the multi-sectional loop 104 that is not an intermediatelength 110 that has no retainers thereon. The empty loop space 112 onthe multi-sectional loop 104 also separates each section 105.

In use, the multi-sectional loop 104 may be used to support a body part,or to close a multi-angled wound or incision. To close a wound, oneintermediate length 110 of one of the sections 105 of themulti-sectional loop 104 is inserted into recess 34 of the sutureinsertion device 26. The suture insertion device 26 is then insertedinto the side of a section of tissue that is the subject of the wound orincision to be closed. With the intermediate length 110 of one of thesections 105 of the multi-sectional loop 104 held within the recess 34of the suture insertion device 26, the suture insertion device is movedin a forwardly direction. As the suture insertion device 26 moves, itholds a portion of the intermediate length 110 within its recess 34. Thesharpened underside 38 of the suture insertion device 26 cuts throughthe mammalian tissue to form a first insertion pathway indicated by thedashed line 122. As the section 105 moves in a forwardly direction, thefirst length 114 and second length 118 retainers flex and remain closeto the perimeter of the length of the multi-sectional loop 104. When thefirst length 114 and second length 118 retainers are completely embeddedwithin the tissue, the user stops the forward travel of the sutureinsertion device 26. The user then begins to remove the suture insertiondevice 26 by moving it in a direction opposed to the first insertionpathway 122. As this occurs, the opposed movement of the sutureinsertion device 26 enables the intermediate length 110 to free itselffrom its location within the recess 34. The finger 36 no longer is ableto hold the intermediate length 110 within the recess 34 when the sutureinsertion device 26 travels in an opposite direction from the insertionpathway 122. As a result, the inserted section of the multi-sectionalloop 104 is freed from its position within the recess 34, and the sutureinsertion device 26 may be completely removed from the tissue of themammal by reversing the direction taken on the insertion pathway. Atthis time any movement of the inserted section in a direction opposed tothe first insertion pathway 122 would result in the first lengthretainers 114 and second length retainers 118 becoming rigid and wouldoppose movement in a direction opposite to the first insertion pathway122. This also results in the first length retainers 114 and secondlength retainers 118 extending outwardly relative to the periphery ofthe inserted section 105 of the multi-sectional loop 104 and into thesurrounding tissue to secure the position of the inserted section 105and the section of tissue held by that inserted section.

The process of wound or incision closure is repeated as described abovewith the insertion of the suture insertion device 26 into a secondsection of tissue to create a second insertion pathway 124 to bind thefirst 126 and second 128 sections of tissue together, as shown in FIG.14A. The process is repeated yet again where the user inserts the sutureinsertion device into the third section of tissue 130 to create a thirdinsertion pathway 132 and to bind the third section of tissue with thefirst 126 and second 128 sections of tissue. FIG. 14B shows themulti-sectional loop 104 in its fully installed position.

It is appreciated that the multi-sectional loop 104 described above mayinclude additional loop sections and may be used to bind wounds thathave multiple sections, not presently shown in FIGS. 14A and 14B. It isfurther appreciated that the multi-sectional loop 104 described above orother multi-sectional loops having additional converging loop portionsmay be used on surgical or medical procedures, such as the bladdersupport procedure described above. It is appreciated that themulti-sectional loop configurations provides additional support points(more than two) in such a procedure. Additional support points mayresult in more effective support and thus a greater chance of success ofthe procedure.

FIG. 15 shows a further alternative embodiment 170 of the presentinvention. A first free length of suture 172 is shown having firstalternating retainers 174 extending peripherally from the length atalternating intervals in a first direction shown by arrow 176. Theembodiment also has a second free length of suture 178 having secondalternating retainers 180 extending peripherally from the length atalternating intervals in a second direction shown by arrow 182. Thefirst 172 and second 178 free lengths of suture are separated by amidsection 184. The first alternating retainers 174 are located alongthe length of the free length of suture 172 at first intervals 186 andthe second alternating retainers 180 are located along the length atsecond intervals 188 so that when the free length of suture 170 isinserted into the tissue of a mammal, and the first 172 and second 178free lengths are placed relatively adjacent to one another, there is nooverlap of first intervals 186 with the second intervals 188, and thusthe first alternating retainers 174 do not overlap the secondalternating retainers 180 as shown in FIG. 15.

FIG. 16 shows a further alternative embodiment of the present invention.FIG. 16 shows a multi-sectional length of suture 196 having free ends198, 200. The suture 196 has four sections of retainers thereon. Thefirst section 202 has first section retainers 204 extending outwardly ina first direction shown by arrow 206. The second 208 and third 210sections have converging retainers thereon. The second section 208 hassecond section retainers 212 facing a second direction shown by arrow214 and the third section 210 has third section retainers 216 facing inthe first direction. The first and second directions are opposed andthus the second 212 and third 216 section retainers face each other atconverging point 215. The third section retainers 216 are also in thesame direction as the first section retainers 204. The fourth section218 has fourth section retainers 220 that face in the second directionand face away from the third section retainers 216 but face in the samedirection as the second section retainers 212.

In use, this embodiment would likely be used to anchor or support anobject or organ, or for closing an endoscopic access port. The second208 and third 210 sections would first be anchored into tissue using thesuture insertion device 26 described above. The suture insertion device26 is shown in FIG. 16 using a straight length 32, however, it isanticipated that a curved suture insertion device 27 may also be usedwhen appropriate. Subsequently, the first section 202 would be anchoredinto neighboring tissue using a curved needle 23, (as shown) or straightneedle, that is either attached (as shown) or detachable from the sutureusing the suture insertion device of the present invention. Similarly,the fourth section 218 would be anchored in the same fashion inneighboring tissue by inserting either a straight or curved detachablesuture insertion device as described above, or by an attachedconventional needle or curved needle 23 as shown. This embodimentprovides for the flexibility in surgical applications where theanchoring of some section of self-retaining suture is needed whereaccess to the area is limited while other sections may have moreaccessibility and an attached needle may be more appropriate.

It is anticipated that the detachable suture insertion device may beautomated to some degree. It is anticipated that the suture insertiondevice may include a mechanism for moving the needle body from a first,initial position to a second installed position within the body. It isanticipated that the mechanism would be moveably linked to the needlebody so that during installation, the mechanism would be able to movethe needle body, and thus the recess and suture therein, from a firstposition to a second installed position within the body upon activation.It is further anticipate that the mechanism may be spring loaded. Such amechanism would provide a further level of accuracy and efficacy inplacing a self-retaining suture in a desired location, especially insituations that are currently present challenges in that regard. Aspring loaded device would provide further accuracy because the lengthof extension and retraction of the needle body could be predeterminedwith great accuracy. Use of an automated mechanism would enable asurgeon to place the suture and any attachment in a specific locationwithout having to reach that location and with greater confidence in theaccuracy of the placement. Incorporation of the present invention wouldfurther increase overall efficacy of the procedure and minimize pain andpossible infection to the patient. These effects would decrease theoverall recovery time and decrease the overall cost of the procedure.

Because it is anticipated that the present invention may be automated tosome degree, it is anticipated that the present invention may be used inan automated surgical system. Due to the high level of accurateplacement of the suture and any attachment, the present invention is anideal candidate to be used with a robotic surgical system or minimallyinvasive surgical procedures.

While the invention has been described in detail with respect tospecific preferred embodiments thereof, numerous modifications to thesespecific embodiments will occur to those skilled in the art upon areading and understanding of the foregoing description; suchmodifications are embraced within the scope of the present invention.

1.-164. (canceled)
 165. An apparatus comprising: (a) a suture insertiondevice comprising: (i) a proximal end configured to be gripped, (ii) adistal end configured to penetrate through tissue, and (iii) a recessedportion disposed proximate to the distal end; and (b) a suturecomprising: (i) a first portion having no retainers that is sized andconfigured to be carried by the recessed portion of the suture insertiondevice as the suture insertion device is advanced distally and separatedfrom the recessed portion as the suture insertion device is withdrawnproximally, and (ii) a second portion that includes a first set ofretainers, wherein the first set of retainers face a first directionaway from the first portion.
 166. The apparatus of claim 165, furthercomprising an attachment feature coupled with a terminal end of thesecond portion.
 167. The apparatus of claim 166, wherein the attachmentfeature includes an enclosed attachment loop.
 168. The apparatus ofclaim 166, wherein the attachment feature includes at least one of atack, a marker, a therapeutic agent, or a chemotherapeutic agent. 169.The apparatus of claim 165, further comprising a third portion thatincludes a second set of retainers.
 170. The apparatus of claim 169,wherein the second set of retainers face the first direction.
 171. Theapparatus of claim 169, wherein the second set of retainers face asecond direction that is opposite to the first direction.
 172. Theapparatus of claim 165, wherein the recessed portion includes aprojection extending distally configured to retain the first portion ofthe suture within the recessed portion as the suture insertion device isadvanced distally into the tissue.
 173. The apparatus of claim 165,wherein each retainer of the first set of retainers includes a retainerbody and a retainer end, wherein the retainer end is disposed fartheraway from the first portion than the retainer body of the same retainer.174. An apparatus comprising: (a) a suture insertion device comprising:(i) a proximal end configured to be gripped, (ii) a distal endconfigured to penetrate through tissue, and (iii) a recessed portiondisposed proximate to the distal end; and (b) a suture comprising: (i)an attachment feature configured to couple the suture with tissue,wherein the attachment feature is disposed at a terminal end of thesuture, (ii) a first portion having no retainers that is sized andconfigured to be carried by the recessed portion of the suture insertiondevice as the suture insertion device is advanced distally and separatedfrom the recessed portion as the suture insertion device is withdrawnproximally, and (iii) a second portion including first set of retainersthat face a first direction toward the attachment feature and away fromthe first portion.
 175. The apparatus of claim 174, wherein theattachment feature includes at least one of a tack, a marker, atherapeutic agent, or a chemotherapeutic agent.
 176. An apparatuscomprising: (a) a first portion having no retainers that is sized andconfigured to be carried by a recessed portion of a suture insertiondevice; (b) a second portion that includes a first set of retainersfacing a first direction away from the first portion; (c) a thirdportion that includes a second set of retainers facing a seconddirection that is opposite to the first direction, wherein the firstportion is disposed between the first and second sets of retainers ofthe second and third portions; (d) a fourth portion that includes athird set of retainers; and (e) a fifth portion having no retainers thatis disposed between the first and third sets of retainers.
 177. Theapparatus of claim 176, wherein the third set of retainers face thefirst direction.
 178. The apparatus of claim 176, wherein the third setof retainers face the second direction.
 179. The apparatus of claim 176,further comprising: (a) a sixth portion that includes a fourth set ofretainers; and (b) a seventh portion having no retainers that isdisposed between the second and fourth sets of retainers.
 180. Theapparatus of claim 179, wherein the fourth set of retainers face thefirst direction.
 181. The apparatus of claim 176, further comprising thesuture insertion device that includes the recessed portion that isconfigured to receive the first portion.
 182. The apparatus of claim176, further comprising: (a) a first terminal end; and (b) a firstneedle coupled with the first terminal end.
 183. The apparatus of claim182, further comprising: (a) a second terminal end disposed opposite thefirst terminal end; and (b) a second needle coupled with the secondterminal end.